Bausch + Lomb licenses exclusive rights from STADA and Xbrane to a biosimilar candidate for Lucentis (ranibizumab) in the United States and Canada
BRIDGEWATER, NJ., BAD VILBEL, Germany, and SOLNA, Stockholm, May 6, 2020 ?
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc.
(NYSE/TSX: BHC), has entered into an exclusive licensing agreement with STADA
Arzneimittel AG and its development partner, Xbrane Biopharma AB, a leading Nordic
biosimilar developer (Nasdaq Stockholm: XBRANE), to commercialize in the United
States and Canada a biosimilar candidate to Lucentis (ranibizumab) that is currently in
development. The companies aim to obtain all currently approved indications for
Lucentis in both the United States and Canada.
European generics and consumer healthcare leader STADA and Xbrane will be jointly
responsible for finalizing development of the biosimilar, currently known as Xlucane.
Xbrane will also provide commercial supply. Bausch + Lomb will be responsible for the
sales, marketing and all other commercialization efforts for the biosimilar candidate in
the United States and Canada following regulatory approval.
?Through this agreement with STADA and Xbrane, we will be able to leverage our
extensive expertise and heritage in the North American ophthalmic market,? said
Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch +
Lomb. ?We believe that, once approved, this biosimilar ranibizumab candidate will be
an excellent addition to our comprehensive eye health portfolio and further deliver on
our commitment of continuing to expand and improve upon our ophthalmic portfolio
for our customers and their patients.?
?We are convinced that biosimilar ranibizumab has strong commercial potential in
North America,? explained STADA CEO Peter Goldschmidt. ?With its deep relationships
with eye care professionals in North America, and an effective salesforce already in
place to promote their comprehensive Pharmaceuticals portfolio, we believe that
Bausch + Lomb is the ideal partner to broaden access to this ophthalmic treatment in
North America.?
Executive Board: Peter Goldschmidt (CEO) / Dr. Wolfgang Ollig / Miguel Pagan Fernandez
Supervisory Board Chairman: Dr. G?nter von Au
05/05/2020 Our Mission ? Your Health Page 2 of 4
?We continue to make good progress in developing biosimilar ranibizumab for North
American markets. Bausch + Lomb has a very strong brand recognition and reputation
amongst ophthalmologists and an existing sales infrastructure to leverage. We are
excited to finalize the final steps towards marketing approval and together with our
partners, bring the product to patients with severe eye diseases in dire need for cost
efficient VEGFa inhibitors in the United States and Canada,? said Martin ?mark, CEO of
Xbrane Biopharma.
Under the terms of the licensing agreement, Bausch + Lomb will make a mid-single
digit million USD up-front payment and will pay further milestone payments subject to
approval and launch of the product in the United States. STADA and Xbrane will also be
entitled to a share of gross profits from sales of the product by Bausch + Lomb, and will
share equally in the proceeds they receive from Bausch + Lomb.
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely
focused on helping people see. Its core businesses include over-the-counter products, dietary
supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care
products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures
and markets one of the most comprehensive product portfolios in the industry, which is
available in approximately 100 countries. For more information, visit www.bausch.com.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a two
pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription
consumer health products. Worldwide, STADA Arzneimittel AG sells its products in
approximately 120 countries. In financial year 2019, STADA achieved adjusted Group sales of
EUR 2,608.6 million and adjusted earnings before interest, taxes, depreciation and amortization
(EBITDA) of EUR 625.5 million. As of December 31, 2019, STADA employed 11,100 people
worldwide.
About Xbrane
Xbrane Biopharma AB develops biological drugs based on a platform technology that provides
significantly lower production costs compared to competing systems. Xbrane?s leading product
Xlucane, a Lucentis? biosimilar candidate, addresses the ?10.4b ophthalmic VEGFa inhibitor
market. Xlucane is in phase III development. Xbrane has additionally four biosimilars in its
pipeline targeting ?8.7b in originator sales. Xbrane?s head office is in Solna, just outside
Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For further
information, please visit www.xbrane.com.
Executive Board: Peter Goldschmidt (CEO) / Dr. Wolfgang Ollig / Miguel Pagan Fernandez
Supervisory Board Chairman: Dr. G?nter von Au
05/05/2020 Our Mission ? Your Health Page 3 of 4
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified
by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would,"
"may," "believes," "estimates," "potential," "target," or "continue" and variations or similar
expressions. These statements are based upon the current expectations and beliefs of Bausch
Health and STADA management and are subject to certain risks and uncertainties that could
cause actual results to differ materially from those described in the forward-looking statements.
These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in
Bausch Health's most recent annual or quarterly report and detailed from time to time in
Bausch Health's other filings with the U.S. Securities and Exchange Commission and the
Canadian Securities Administrators, which factors are incorporated herein by reference. Readers
are cautioned not to place undue reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. Bausch Health and STADA
undertake no obligation to update any of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect actual outcomes, unless required
by law.
Contact information for journalists:
Bausch + Lomb
Media Contacts
Sam Ewing
sam.ewing@zenogroup.com
+1 (917) 415-3842
STADA
STADA Arzneimittel AG
Media Relations
Stadastrasse 2-18
61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
Fax: +49 (0) 6101 603-215
E-Mail: press@stada.de
Or visit us on the Internet at www.stada.com/press